Obesity &Amp; OverweightPCAT-GMDNCT07144670
Fat Around Heart Arteries as a Measure of Inflammation in Patients With Glycometabolic Disease
An observational study of Obesity &Amp; Overweight and Obesity Type 2 Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.
Trial summary
In this study, the objective is to investigate inflammation in the arteries of the heart. A heart CT scan (CCTA) will be used to measure inflammation by assessing the fat tissue surrounding the arteries of the heart. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Obesity &Amp; Overweight, Obesity Type 2 Diabetes Mellitus, Type 2 Diabetes (T2DM)
- How many people
- 747 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2016to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: CARPE-DM: Participants with type 2 diabetes who were cardiac asymptomatic and had no history of CAD. Participants were recruited from the Endocrinology Outpatient Clinic and the Retina Photographhy Clinic at Odense University Hospital, Svendborg, Denmark. DANCAP: Participants in the age range 65-75 years were recruitted from the large Danish Cardiovascular Screening (DANCAVAS) at Odense University Hospital (OUH), Svendborg Hospital, Denmark. Participants were cardiac asymptomatic and had no history of CAD.
Who may be able to join
- Above 18 years
- Capable of giving written informed consent
Who cannot join
- History of CAD
- Symtoms of CAD (angina)
- Any tachyarrhythmias making CCTA impossible
- Estimated glomerular filtration rate (eGFR) under 45 ml/min
- Allergy to iodine contrast
- Critical illness with life expectancy less than 1 year
- Documented heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Pericoronary Adipose Tissue Attenuation in Glycometabolic Diseases
In this study, the objective is to investigate inflammation in the arteries of the heart. A heart CT scan (CCTA) will be used to measure inflammation by assessing the fat tissue surrounding the arteries of the heart. Participants with and without type 2 diabetes who have no heart symptoms have been examined and had a CCTA scan performed.
This study aims to answer the following questions:
- Is inflammation in the surrounding fat tissue of the heart arteries associated with the following glycometabolic conditions: I) Obesity ii) Prediabetes iii) Type 2 diabetes
Read the detailed description
Background and significance:
Inflammation in the coronary arteries is a key driver of cardiovascular (CV) disease, particularly in individuals with glycometabolic conditions such as obesity and diabetes. However, traditional biomarkers have limited accuracy in detecting coronary inflammation.
Coronary CT angiography (CCTA) allows for the non-invasive measurement of pericoronary adipose tissue (PCAT) attenuation - the fat surrounding coronary arteries. PCAT and the underlying vessels engage in bidirectional communication, and inflammation alters the structure of PCAT, which can be detected by CCTA.
Glycometabolic diseases promote atherosclerosis through endothelial dysfunction and accumulation of inflammatory cells. Obesity and diabetes are both associated with enlarged adipocytes, which may influence PCAT attenuation by lowering its Hounsfield Unit values, potentially masking underlying inflammation. To date, no studies have thoroughly addressed the possibility that PCAT attenuation may be underestimated in this high-risk CV population.
The PCAT-GMD study is a post-hoc analysis of two trials - CARPE-DM (NCT03016910) and DANCAP (NCT04525508) - aiming to evaluate the relationship between PCAT attenuation and the following glycometabolic conditions:
- Obesity (BMI)
- Prediabetes (HbA1c)
- Type 2 diabetes mellitus
Setting and study population:
A single-center cross-sectional, observational study at Odense University Hospital, Svendborg, Denmark. The study enrollment began in March 2016 and ended in July 2019. The study population included 747 cardiovascularly asymptomatic men with and without diabetes.
Examinations:
All participants underwent CCTA.
Additional assessments included:
- Blood pressure and heart rate
- Anthropometrics: height, weight, waist-to-hip ratio
- Blood and urine sampling
- Medical history
- Conditions
- Obesity &Amp; Overweight, Obesity Type 2 Diabetes Mellitus, Type 2 Diabetes (T2DM), Prediabetes, Inflammation, Adipose Tissue
- Keywords
- inflammation, type 2 diabetes mellitus, diabetes, prediabetes, obesity, pericoronary adipose tissue, PCAT
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2, Prediabetic State, Inflammation, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obesity (BMI) | Categorical: Normal (25-30), overweight (>25-30), obesity 1 (>30-35), obesity 2+ (>35) | |
| Prediabetes | Categorical: Normal (<39), Prediabtes (39-47 mmol/mol) | |
| Type 2 Diabetes Mellitus | Categorical: Without diabetes, with diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCAT Attenuation [Hounsfield Units (HU)] measured by coronary CT angiography
PCAT attenuation [HU] will be assessed for correlation with the following variables:
- BMI [kg/m²] [Continously, and categorized as normal (ref), overweight, obesity class 1, obesity class 2+].
- Prediabetes, defined as HbA1c: 39-47 mmol/mol [Categorical: no(ref)/yes].
- Type 2 diabetes mellitus, defined by WHO criteria [Categorical: no(ref)/yes].
Measured: Baseline
Secondary outcomes (1)
PCAT Attenuation [HU] measured by coronary CT angiography
Analyses will assess whether BMI (kg/m²) mediates the correlation between glycemic status (prediabetes [HbA1c 39-47 mmol/mol, categorical: no/yes] or type 2 diabetes mellitus [WHO criteria], categorical: no/yes] and PCAT attenuation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study startMar 2016
- Primary completion1 Jul 2019
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 747 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrine Schultz Overgaard, Odense University Hospital
- Investigators
- Kenneth Egstrup, Professor, Principal investigator, Cardiovascular Research Unit, OUH Svendborg Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144670
- Sponsor's protocol ID
- PCAT-GMD
- Acronym
- PCAT-GMD
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Pericoronary Adipose Tissue Attenuation in Glycometabolic Diseases
- ClinicalTrials.gov ID
- NCT07144670
- Acronym / sponsor ID
- PCAT-GMD / PCAT-GMD
- Conditions
- Obesity &Amp; Overweight, Obesity Type 2 Diabetes Mellitus, Type 2 Diabetes (T2DM), Prediabetes, Inflammation, Adipose Tissue
- Keywords
- inflammation, type 2 diabetes mellitus, diabetes, prediabetes, obesity, pericoronary adipose tissue, PCAT
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 747 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the objective is to investigate inflammation in the arteries of the heart. A heart CT scan (CCTA) will be used to measure inflammation by assessing the fat tissue surrounding the arteries of the heart. Participants with and without type 2 diabetes who have no heart symptoms have been examined and had a CCTA scan performed.
This study aims to answer the following questions:
- Is inflammation in the surrounding fat tissue of the heart arteries associated with the following glycometabolic conditions: I) Obesity ii) Prediabetes iii) Type 2 diabetes
Detailed description
Background and significance:
Inflammation in the coronary arteries is a key driver of cardiovascular (CV) disease, particularly in individuals with glycometabolic conditions such as obesity and diabetes. However, traditional biomarkers have limited accuracy in detecting coronary inflammation.
Coronary CT angiography (CCTA) allows for the non-invasive measurement of pericoronary adipose tissue (PCAT) attenuation - the fat surrounding coronary arteries. PCAT and the underlying vessels engage in bidirectional communication, and inflammation alters the structure of PCAT, which can be detected by CCTA.
Glycometabolic diseases promote atherosclerosis through endothelial dysfunction and accumulation of inflammatory cells. Obesity and diabetes are both associated with enlarged adipocytes, which may influence PCAT attenuation by lowering its Hounsfield Unit values, potentially masking underlying inflammation. To date, no studies have thoroughly addressed the possibility that PCAT attenuation may be underestimated in this high-risk CV population.
The PCAT-GMD study is a post-hoc analysis of two trials - CARPE-DM (NCT03016910) and DANCAP (NCT04525508) - aiming to evaluate the relationship between PCAT attenuation and the following glycometabolic conditions:
- Obesity (BMI)
- Prediabetes (HbA1c)
- Type 2 diabetes mellitus
Setting and study population:
A single-center cross-sectional, observational study at Odense University Hospital, Svendborg, Denmark. The study enrollment began in March 2016 and ended in July 2019. The study population included 747 cardiovascularly asymptomatic men with and without diabetes.
Examinations:
All participants underwent CCTA.
Additional assessments included:
- Blood pressure and heart rate
- Anthropometrics: height, weight, waist-to-hip ratio
- Blood and urine sampling
- Medical history
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obesity (BMI) | – | –Categorical: Normal (25-30), overweight (>25-30), obesity 1 (>30-35), obesity 2+ (>35) |
| Prediabetes | – | –Categorical: Normal (<39), Prediabtes (39-47 mmol/mol) |
| Type 2 Diabetes Mellitus | – | –Categorical: Without diabetes, with diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CARPE-DM: Participants with type 2 diabetes who were cardiac asymptomatic and had no history of CAD. Participants were recruited from the Endocrinology Outpatient Clinic and the Retina Photographhy Clinic at Odense University Hospital, Svendborg, Denmark. DANCAP: Participants in the age range 65-75 years were recruitted from the large Danish Cardiovascular Screening (DANCAVAS) at Odense University Hospital (OUH), Svendborg Hospital, Denmark. Participants were cardiac asymptomatic and had no history of CAD.
Key inclusion criteria (2 listed)
- Above 18 years
- Capable of giving written informed consent
Key exclusion criteria (7 listed)
- History of CAD
- Symtoms of CAD (angina)
- Any tachyarrhythmias making CCTA impossible
- Estimated glomerular filtration rate (eGFR) under 45 ml/min
- Allergy to iodine contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PCAT Attenuation [Hounsfield Units (HU)] measured by coronary CT angiography
Time frame: Baseline
PCAT attenuation [HU] will be assessed for correlation with the following variables: * BMI [kg/m²] [Continously, and categorized as normal (ref), overweight, obesity class 1, obesity class 2+]. * Prediabetes, defined as HbA1c: 39-47 mmol/mol [Categorical: no(ref)/yes]. * Type 2 diabetes mellitus, defined by WHO criteria [Categorical: no(ref)/yes].
1 secondary outcome
PCAT Attenuation [HU] measured by coronary CT angiography
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Obesity &Amp; Overweight
RecruitingPhase 2
UBT251 Injection Phase II Clinical Study (CKD)
Obesity &Amp; Overweight, Chronic Kidney Disease
Active, not recruiting
E-Bike Commuting and Health in Overweight College Students
Obesity &Amp; Overweight, Sedentary Behaviors
Not yet recruiting
EAT SMART Teen Study
Obesity &Amp; Overweight
Active, not recruiting
Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity
Obesity &Amp;Amp;Amp; Overweight, Environmental Exposure
Active, not recruiting
Can Gut Bacteria Predict Who Benefits Most From Exercise? A Gut Supplement to Help Exercise Non-Responders
Obesity &Amp; Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Egstrup, Professor principal investigator
Cardiovascular Research Unit, OUH Svendborg Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity &Amp; Overweight and Obesity Type 2 Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCAT Attenuation [Hounsfield Units (HU)] measured by coronary CT angiography (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.